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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceVASOSEAL ELITE VHD/ES DEVICE
Classification Namedevice, hemostasis, vascular
Generic Namedevice, hemostasis, vascular
Applicant
St. Jude Medical, Inc.
177 e.county rd. b east
st paul, MN 55117
PMA NumberP920004
Supplement NumberS018
Date Received03/26/2002
Decision Date08/13/2002
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE USE OF A SINGLE SPONGE COLLAGEN PLUG. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES VASOSEAL ELITE VHD OR ES DEVICE AND IS INDICATED FOR: "SEALING THE FEMORAL ARTERIAL PUNCTURE SITE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC AND INTERVENTIONAL CATHETERIZATION PROCEDURES USING AN 8 FRENCH OR SMALLER PROCEDURAL SHEATH AND USING A RETROGRADE APPROACH. THE VASOSEAL ELITE VHD/ES DEVICE REDUCES TIME TO HEMOSTASIS, AND AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC AND INTERVENTIONAL CATHETERIZATION PROCEDURES. IN ADDITION, THE VASOSEAL ELITE VHD/ES DEVICE REDUCES TIME TO DISCHARGE IN DIAGNOSTIC PATIENTS RECEIVING 5-6 FRENCH PROCEDURAL SHEATHS. VASOSEAL ELITE VHD/ES DEVICE REDUCES TIME TO HEMOSTASIS IN INTERVENTIONAL, PATIENTS, WHEN IMMEDIATE SHEATH REMOVAL IS DESIRED." THE VASOSEAL ELITE VHD DEVICE INDICATIONS INCLUDE THE STATEMENT: "HOWEVER, EARLY AMBULATION IN THESE PATIENTS HAS NOT BEEN DETERMINED."
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